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評估應進一步涵蓋資源,,包括人員、廠房,、設備和儀器,、公用設施、質(zhì)量控制,、文件,、計算機化系統(tǒng)、確認與驗證以及廢棄物管理,。 4.5. The assessment to determine feasibility and readiness for technologytransfer may include technical, business, regulatory and legal aspects. 確定技術轉移的可行性和準備情況的評估可能包括技術,、商業(yè)、監(jiān)管和法律方面,。 5. Organization and management 組織和管理 5.1. All technology transfer activities should be organized andplanned. 所有技術轉移活動均應得到組織和計劃,。 5.2. There should be a formal agreement between the parties whichspecifies the responsibilities of each party before, during and after transfer.The agreement should cover, for example, data management, data integrity,documentation and validation. 雙方之間應有一份正式協(xié)議,,具體規(guī)定雙方在轉移之前、期間和之后的責任,。協(xié)議應包括,,例如,數(shù)據(jù)管理,,數(shù)據(jù)完整性,,文件記錄和驗證。 5.3. All the necessary activities to be executed during thetechnology transfer project should be identified, organized and documented atthe start of the project. Responsibilities should be defined. 在技術轉移項目開始時,,應確定、組織和記錄技術轉讓項目期間執(zhí)行的所有必要活動,。應該定義責任,。 5.4. The SU should provide the necessary documentation relating tothe process, product or procedure to be transferred.